Intake of Beta-glucan and Postprandial Regulation of Blood Glucose Metabolism in Healthy Subjects

Not Applicable

Completed

• Conditions: Satiety; Post Prandial Blood Glucose; Gut Microbiota
• Interventions: Other: 3.5 g beta-glucan; Other: 8 g beta-glucan; Other: 0.5 g beta-glucan

• Registration Number: NCT03293693
• Lead Sponsor: Oslo Metropolitan University

Brief Summary

The overall aim is to investigate the intake of beta-glucan in relation to glucose metabolism and satiety in a postprandial study with healthy subjects. The potential effects will be related to changes in the gut microbiota, the circulating levels of short chain fatty acids, inflammation and gene expression in peripheral mononuclear blood cells

Detailed Description

The intervention study will have a fixed order, cross-over design with three test meals containing low (0.5 g / 100 g of product), medium (3.5 g / 100 g of product) and high (8 g / 100 g product) amount of beta -glucans, respectively. The test meals are in the form of cereals. All participants will eat the three test meals three constitutive days with 2 weeks apart. At day four, the participants will perform a postprandial glucose test (OGTT, 75 g glucose in 150 ml water) at Oslo and Akershus University College. Blood samples will be taken before and at different time points after glucose test.

At the screening visit the participants will be asked to limit the intake of dietary fiber from grains two weeks prior to the baseline visit (0) and during the study. Otherwise, participants will be asked not to change their diet and exercise habits during the study period.

At the baseline visit (visit 0) an OGTT will be performed. OGTT will also be performed at visit 1, 3 and 5 after intake of low, medium and high beta-glucan, respectively.

The participants will receive the test meals at visit 1, 2 and 4.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2017-03-10
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-25
• Last Update Submitted: 2017-09-25
• Study First Posted: 2017-09-26
• Last Update Posted: 2017-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• BMI between 18,5 and 27 kg/m2
• Fasting plasma glucose ≤ 6.1 mmol/l

Exclusion Criteria

• Chronic metabolic diseases such as diabetes type 1 and 2, coronary heart disease and cancer the last 6 months.
• Intestinal diseases such as chrons disease, ulcerative colitis and irritable bowel syndrome.
• Food allergy and intolerances towards grain and dairy products.
• Pregnant and lactating
• Smokers
• Fasting blood glucose ≥ 6.1 mmol/L
• CRP > 10 mg/L, measured at baseline (visit 0)
• BMI <18,5 and >27 kg/m2
• Planned weight reduction and or ± 5% weight change over the past three months.
• Use of antibiotics last 3 months before study entry and during the study period
• Use of probiotics the last month before study entry and during the study period
• Blood donor last 2 months before study entry and or during the study period
• Not willing to end the use of dietary supplements four weeks prior to study entry and throughout the study period
• Alcohol consumption > 40g / day
• Hormone treatments (except contraceptives)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test meal 2	3.5 g beta-glucan	Test meal with 3.5 g beta-glucan
Test meal 3	8 g beta-glucan	Test meal with 8 g beta-glucan
Test meal 1	0.5 g beta-glucan	Test meal with 0.5 g beta-glucan

Primary Outcome Measures

Name	Time	Method
Postprandial insulin response	At day 4	insulin response after OGTT
Postprandial blood glucose response	At day 4	Blood glucose response after OGTT

Secondary Outcome Measures

Name	Time	Method
Free fatty acids	At day 4	Plasma free fatty acids are measured after intake of test meals
Microbiota analyses in feces	At day 4	Microbiota analyses in feces are measured before and after intake of test meals. Change in microbiota will be analysed
Quantitative assessment of metabolites in urine	At day 4	Morning urine are collected before and after intake of test meals. Metabolites in urine will be quantified using UHPLC-qTOF-MS. Change in metabolites before and after test meals will be analyzed
H2 breath response	At day 4	H2 breath response after OGTT
Serum triglyceride response	At day 4	Triglyceride response are measured are measured after OGTT
Inflammatory markers (e.g. CRP)	At day 4	Response in Inflammatory markers are measured after OGTT
mRNA analyses in PBMC (RT-PCR)	At day 4	PBMC are collected before and after OGTT. The change in mRNA level will be analyzed
Serum cholesterol	At day 4	Serum cholesterol are measured fasting after intake of test meals
hunger and satiety hormones (e.g. GLP1)	At day 4	The response in hunger and satiety hormones after OGTT
Quantitative assessment of metabolites in plasma	At day 4	Plasma for metabolome analyses are collected after intake of test meals. Metabolites in plasma will be quantified using UHPLC-qTOF-MS.
Visual analogue scale (VAS)	At day 3	Subjective hunger and satiety will be estimated after intake of test meals for three days

Trial Locations

Locations (1)

Oslo and Akershus university College; 🇳🇴 Oslo, Norway